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FDA 510(k)

ULTRAZYME PLUS HBD

K-Number: K821877 · 1982-07-14

ApplicantHarleco Diagnostics
Decision Date1982-07-14
Product CodeJMK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS HBD is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1982-07-14 under 510(k) number K821877. The device is classified under product code JMK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAZYME PLUS HBD?

ULTRAZYME PLUS HBD is a medical device that received FDA 510(k) clearance on 1982-07-14. The listed applicant is Harleco Diagnostics. The 510(k) number is K821877.

When did ULTRAZYME PLUS HBD receive FDA 510(k) clearance?

ULTRAZYME PLUS HBD received FDA 510(k) clearance on 1982-07-14, under 510(k) number K821877.

Who is the listed applicant for ULTRAZYME PLUS HBD?

The FDA 510(k) record lists Harleco Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAZYME PLUS HBD?

The FDA product code for ULTRAZYME PLUS HBD is JMK.

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Other records listing Harleco Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K823147URIC ACID STANDARD, 8MG/DL #65078K822852TRIGLYCERIDE CALIBRATORK822323ULTRACHEM BUN-UV, 65080 & 65081K821880ULTRA CHEM ALBK821879ULTRACHEM T.P.K821872ULTRACHEM URIC ACID AIDH

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Related Devices (Code: JMK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983860MTM BIOSCANNER K TEST STRIPS, CAT # BSA610Polymer Technology Systems, Inc.K981865MTM BIOSCANNER K TEST STRIPSPolymer Technology Systems, Inc.K953452KETOREX C SANWAIhara Medics U.S., Inc.K941427SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)Teco DiagnosticsK862319HBDH (OPTIMIZED) REAGENTSigma Chemical Co.K843774RAICHEM X-HBDH REAGENTReagents Applications, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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